Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia
Information source: Universidad de Granada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: trazodone, pregabalin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Universidad de Granada Official(s) and/or principal investigator(s): Elena P Calandre, MD, Principal Investigator, Affiliation: Universidad de Granada
Summary
The study has a double purpose: a first phase intends to assess the effectiveness and
tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties,
in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of
pregabalin to patients who have shown a partial response to trazodone additionally improves
fibromyalgia symptomatology.
Clinical Details
Official title: Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
Secondary outcome: Change from baseline to endpoint in the scores of the Pittsburgh Sleep Quality Inventory, the Brief Pain Inventory, the Beck Depression Inventory, and the Hospital Anxiety and Depression ScaleDiscontinuation rates due to treatment-related adverse events, proportion of patients experiencing any adverse event, proportion of patients experiencing serious adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients diagnosed of fibromyalgia according to the American College of Rheumatology
criteria
- written, informed consent
- able to understand and comply with the requirements of the study
Exclusion Criteria:
- pregnancy or breastfeeding
- unwillingness to discontinue other prescribed medications before entering in the
study
- patients who had previously received trazodone without improvement or who did not
tolerate the drug
- patients who had previously received pregabalin without improvement or who did not
tolerate the drug (only for the phase II of the study)
Locations and Contacts
Instituto de Neurociencias, Granada 18012, Spain
Additional Information
Web page of the Institute of Neuroscience of the University of Granada
Starting date: April 2008
Last updated: December 1, 2014
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